DTRAX® Spinal System DX-22-100

GUDID 10852776006086

The DTRAX® Spinal System is a set of instruments intended and indicated for access and preparation of a spinal joint to aid in fusion.

PROVIDENCE MEDICAL TECHNOLOGY, INC.

Spinal endoscopic-access system Spinal endoscopic-access system

• Primary Device ID: 10852776006086
• NIH Device Record Key: a0b1a72a-e599-4d5d-b787-195186a81dc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DTRAX® Spinal System
• Version Model Number: DX-22-100
• Catalog Number: DX-22-100
• Company DUNS: 969820245
• Company Name: PROVIDENCE MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852776006089 [Primary]
GS1	10852776006086 [Package]; Contains: 00852776006089; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180876

FDA Product Code

• HRX: Arthroscope

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[10852776006086]

Radiation Sterilization

[10852776006086]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-29
• Device Publish Date: 2017-06-27

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